Hudson RICA Sheridan, Sher-I-Bronch Accessory Pack, Teleflex Medical, Research Triangle Park, NC 27709. Indicated for us
FDA device recall Z-1943-2009 · posted 2009-09-16 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- The tether attaching to the double swivel cap may partially or completely break at the attachment points, resulting in the potential of the accidental aspiration of the tether into the patient's lungs.
- Action taken
- Teleflex Medical, Inc. notified consignees via overnight mail starting July 31, 2009 requesting acknowledgement of the recall and a request to return all of the affected product. Distributors were instructed to forward the letter to their consignees and retrieve relevant product from those locations. Affected product received by Teleflex Medical will be destroyed or reworked and replacement product or credit will be provided to the consignee. For further information, contact Teleflex Medical at 1-919-433-4986.
- Root cause
- Process control
- Status
- Terminated
- Product code
- BZA
- Quantity affected
- 569,465 (total for all types)
- Distribution
- U.S. Nationwide, Canada, Mexico, Europe, India, Asia Pacific Rim, South and Latin America. (Including: Malaysia, Hong Kong, Vietnam, Singapore, Thailand, Korea, China, Japan, Philippines, Australia, N
- Date initiated
- 2009-07-31
- Date posted
- 2009-09-16
- Date terminated
- 2011-09-15
- Location
- Durham, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DOUBLE-SWIVEL CONNECTOR (K850964) | Sheridan Catheter Corp. | 1985-05-14 |